MedTrace Logo

Safety and Efficacy of AZD4547 in Combination With Fulvestrant vs. Fulvestrant Alone in ER+ Breast Cancer Patients

NCT01202591 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2016-02-11

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to assess the safety and effectiveness of AZD4547 in combination with fulvestrant vs. fulvestrant alone in ER+ breast cancer patients with FGFR1 polysomy (FISH4/5) or gene amplification (FISH 6)

Conditions

  • FGFR Inhibition, Pharmacokinetics, Biomarkers
  • ER+ Breast Cancer

Interventions

DRUG

AZD4547

Tablet oral twice daily

DRUG

Exemestane

Tablet oral once daily

DRUG

Placebo

Tablet oral twice daily

DRUG

Fulvestrant

A monthly intramuscular injection of a depot formulation with a loading dose 14 days after initial administration

Sponsors & Collaborators

Principal Investigators

  • Donal Landers · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2014-09-30
Completion
2014-10-31

Countries

  • Belgium
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Romania
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01202591 on ClinicalTrials.gov